Informations générales (source: ClinicalTrials.gov)
Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Interventional
Phase 1
Novartis Pharmaceuticals (Voir sur ClinicalTrials)
octobre 2024
janvier 2031
19 mai 2026
The purpose of this study is to evaluate the safety, tolerability, dosimetry and
preliminary efficacy of [177Lu]Lu-NNS309 and the safety and imaging properties of
[68Ga]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic
pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2-
ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and
colorectal cancer (CRC).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | D�sir�e DEANDREIS | 08/06/2026 07:05:05 | Contacter | ||
Critères
Tous
- Age ≥ 18 years old
- Patients with one of the following indications:
- Locally advanced unresectable or metastatic PDAC with disease progression following,
or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive
such therapy
- Locally advanced unresectable or metastatic NSCLC without any actionable genomic
alterations with disease progression following, or intolerance to chemotherapy and
immunotherapy, unless patient was ineligible to receive such therapy, or locally
advanced unresectable or metastatic NSCLC with an actionable genomic alteration with
disease progression following, or intolerance to targeted therapy, unless patient
was ineligible to receive such therapy
- Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with
disease progression following, or intolerance to, at least 2 lines of therapy,
unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic TNBC with disease progression following,
or intolerance to, at least 2 lines of therapy, unless patient was ineligible to
receive such therapy
- (Dose escalation part only) Locally advanced or metastatic unresectable CRC with
disease progression following, or intolerance to cytotoxic chemotherapy, unless
patient was ineligible to receive such therapy. Patients with known microsatellite
instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have
had disease progression following, or intolerance to immune checkpoint inhibitor
therapy, unless patient was ineligible to receive such therapy
- Patients must have lesions showing 68Ga-NNS309 uptake
Exclusion Criteria:
- Absolute neutrophil count (ANC) < 1.5 x 109/L, hemoglobin < 9 g/dL, or platelet
count < 100 x 109/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- Creatinine clearance < 60 mL/min
- Unmanageable urinary tract obstruction or urinary incontinence
- Radiation therapy within 4 weeks prior to the first dose of [177Lu]Lu-NNS309
Other protocol-defined inclusion/exclusion criteria may apply.